The following data is part of a premarket notification filed by Soundcure Inc with the FDA for Soundcure Serenade Tinnitus Treatment System.
| Device ID | K111293 |
| 510k Number | K111293 |
| Device Name: | SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM |
| Classification | Masker, Tinnitus |
| Applicant | SOUNDCURE INC 560 SOUTH WINCHESTER BLVD SUITE 500 San Jose, CA 95128 |
| Contact | Nancy Lince |
| Correspondent | Nancy Lince SOUNDCURE INC 560 SOUTH WINCHESTER BLVD SUITE 500 San Jose, CA 95128 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-06 |
| Decision Date | 2011-08-24 |
| Summary: | summary |